Apparatus and method for cleaning an instrument

ABSTRACT

An apparatus for cleaning an instrument with a cleaning fluid includes a vessel defining a chamber and a port for at least partially filling the chamber with the fluid. The apparatus further includes an ultrasonic transducer for delivering ultrasonic energy to the fluid, and a vacuum pump for depressurizing the chamber. The apparatus further includes a rotatable device removably disposable in the chamber and having a rack defining a cavity for supporting the instrument. The rotatable device also has a fluid delivery member extending toward the cavity and having a fluid channel between an inlet and an outlet. The apparatus further includes a fluid transmission system in fluid communication with the chamber and the fluid channel of the fluid delivery member for circulating the fluid from the chamber through the fluid channel of the fluid delivery member. A method of cleaning an instrument is also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to and all the benefits of U.S.Provisional Patent Application Ser. No. 61/916,477 filed on Dec. 16,2013, the contents of which are expressly incorporated herein byreference in their entirety.

FIELD OF THE INVENTION

The present disclosure relates generally to an apparatus and method forcleaning an instrument.

BACKGROUND

Medical instruments, including those which are classified as endoscopicand non-endoscopic, often get coated with biological fluid, such asblood, when used during a medical procedure. In some cases, thesemedical instruments can be reused after they have been properly cleaned,reconditioned, sterilized, and/or decontaminated. Current cleaningapparatuses typically subject the instruments to a high temperatureand/or a cleaning fluid(s). However, in some instances, the biologicalfluid(s) may harden or dry before cleaning. Accordingly, the biologicalfluid(s) may undesirably remain on interior and/or exterior surfaces ofthe instruments after cleaning. Additionally, the inventors of thesubject application discovered that some cleaning apparatuses do notallow the cleaning fluid(s) to adequately contact the interior of theinstrument. Accordingly, it may be difficult to effectively remove thebiological fluid that is deposited within the instrument. For at leastthese reasons, there is an opportunity to develop an improved apparatusand method for cleaning instruments, such as medical instruments.

SUMMARY

An apparatus for cleaning an instrument with a cleaning fluid comprisesa vessel defining a chamber and a port for at least partially fillingthe chamber with the cleaning fluid. The apparatus further comprises anultrasonic transducer operatively coupled to the vessel for deliveringultrasonic energy to the cleaning fluid that is disposed within thechamber. The apparatus further comprises a vacuum pump operativelycoupled to the vessel for depressurizing the chamber. The apparatusfurther comprises a rotatable device removably disposable in the chamberand defining a longitudinal axis. The rotatable device has a rackdefining a cavity for supporting the instrument. The rotatable devicefurther has a fluid delivery member extending towards the cavity of therack. The fluid delivery member has an inlet and an outlet, and thefluid delivery member defines a fluid channel extending between theinlet and the outlet. The apparatus further comprises a fluidtransmission system in fluid communication with the chamber and thefluid channel of the fluid delivery member for circulating the cleaningfluid from the chamber through the fluid channel of the fluid deliverymember.

A method for cleaning an instrument is also provided. The methodcomprises loading the instrument in the cavity of the rack, placing therotatable device inside the chamber of the vessel, at least partiallyfilling the chamber with the cleaning fluid to submerge the instrumentin the cleaning fluid, sonicating the cleaning fluid in the chamber withthe ultrasonic transducer, and circulating the cleaning fluid throughthe fluid channel in the fluid delivery member such that the cleaningfluid exits the fluid delivery member to contact the interior of theinstrument.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present disclosure will be readily appreciated, as thesame becomes better understood by reference to the following detaileddescription, when considered in connection with the accompanyingdrawings. It is to be appreciated that the figures are merelyillustrative and are not necessarily drawn to scale.

FIG. 1 is a semi-schematic, perspective view of an embodiment of thecleaning apparatus.

FIG. 2 is a perspective view of a housing of the cleaning apparatus.

FIG. 3 is a perspective view of the housing of FIG. 2 with the sidewalls removed.

FIG. 4 is a perspective view of a portion of the housing of the cleaningapparatus showing a motor for opening and closing a front door.

FIG. 5 is a perspective view of a vessel of the cleaning apparatus inaccordance with one embodiment.

FIG. 5A is a perspective view of the vessel of FIG. 5 without theinjectors, valves, and ultrasonic transducers.

FIG. 6 is an end view of the vessel shown in FIG. 5.

FIG. 7 is a perspective view of a portion of the cleaning apparatusshowing a rotatable device being loaded within a chamber of the vessel.

FIG. 8 is a perspective view of an embodiment of the rotatable devicefor the cleaning apparatus.

FIG. 9 is a perspective view of an embodiment of a rack for therotatable device where the rack defines a cavity with an instrumentsupported in the cavity.

FIG. 10 is a cut-away view of a portion of the rack with instrumentsdisposed therein.

FIG. 11 is a cross-sectional view of a portion of the rack showing afluid delivery member.

FIGS. 12A through 12D are perspective views of the cleaning apparatusillustrating the loading of the rotatable device in the chamber of thevessel.

DETAILED DESCRIPTION

Referring now to the figures, wherein like numerals indicatecorresponding parts throughout the several views, an apparatus 10 forcleaning an instrument 12 is shown throughout FIGS. 1-5, 5A, 6-11, and12A-12D and is described in detail below. The apparatus 10 may be usedto effectively and efficiently clean the interior and/or exterior of theinstrument 12 with a cleaning fluid. In an example, the apparatus 10 maybe used to clean a single (i.e., one) instrument 12. In another example,the apparatus 10 may be used to clean a plurality of (i.e. two or more)instruments at the same time.

The instrument 12 may be any type of article or device that requirescleaning. In an example, the instrument 12 is a medical instrument, suchas an endoscopic instrument or a non-endoscopic instrument. Theinstrument 12 typically has an interior and an exterior. In someinstances, however, the instrument 12 may have an exterior, but not aninterior. Non-limiting examples of the instrument 12 include trocars(such as ENDOPATH® XCEL® trocars and ENDOPATH® BASX trocars availablefrom Ethicon Endo-Surgery, Inc.), laparoscopic hand instruments (such asENSEAL® G2 curved and straight tissue sealers available from EthiconEndo-Surgery, Inc. and ENDO DISSECT™, Short and ENDO SHEARS™ Shortinstruments available from Coviden Surgical), suture passers, reamers,drill bits, saws, precision blades, oscillating blades, arthroscopicinstruments (such as DYONICS™ arthroscopic drill bits and saw bladesavailable from Smith & Nephew, arthroscopic instruments available fromLinvatec Corporation, and arthroscopic instruments available fromStryker Corporation), and/or the like.

It is to be understood that the instrument 12 may also be an instrumentother than a medical instrument. Non-limiting examples of otherinstruments include cooking instruments (such as knives, forks, spoons,measuring instruments, etc.), household instruments, laboratoryinstruments (such as test tubes, beakers, thermometers, etc.),veterinary instruments, and/or the like.

In certain embodiments, the interior of the instrument 12 may beunderstood to include at least one surface defining a lumen of theinstrument 12. In other embodiments, the interior of the instrument 12may be understood as a surface that is not readily visible while theinstrument 12 is intact (i.e., not disassembled).

In certain embodiments, the instrument 12 may be a used medical devicethat is received from one or more hospitals. Once the used medicaldevices arrive at the facility, depending on the condition of the usedmedical device, the used medical device may be also reconditioned. Thestep of reconditioning may include sharpening edges, removing burrs,and/or rebuilding the used medical device. The reconditioned medicaldevice may be tested using one or more of the following testing systems:electrical profiling, examining high-speed rotation, measuringcurvature, evaluating pressure decay, or other device-specificfunctional tests.

The apparatus 10 may be used to clean the instrument 12. Cleaning of theinstrument 12 may include removing a substance (e.g., dirt, debris,particles of hardened biological fluid, the biological fluidsthemselves, stains, etc.) from the interior and/or exterior of theinstrument 12. In certain embodiments, cleaning describe a process fordisinfecting, sterilizing, and/or decontaminating the interior and/orexterior of the instrument 12.

The cleaning fluid may be any type of cleaning fluid that will suitablyclean the instrument 12. Examples of suitable cleaning fluids includechemical-based cleaning fluids and/or natural cleaning fluids. Examplesof specific cleaning fluids that may be used include enzymatic and/orperoxide-based cleaning fluids, water, detergents, and/or combinationsthereof.

An embodiment of the apparatus 10 is shown in FIG. 1. In thisembodiment, the apparatus 10 is capable of cleaning several (e.g., tensor hundreds) of instruments 12 at the same time. The apparatus 10 asshown may be used in large-scale environments and/or for commercialpurposes where a high quantity (e.g., tens or hundreds) of instruments12 are used, such as in hospitals, medical laboratories, schools, and/orthe like. In large-scale environments, the apparatus 10 may beconfigured to operate in a single room, such as in a laboratory orcleaning room of a hospital. Alternatively, and as shown in the exampledepicted in FIG. 1, the apparatus 10 may be configured to be operatedbetween two rooms, where the instrument(s) 12 is/are loaded into theapparatus 10 in a first room and the cleaned instrument(s) 12 is/areunloaded in a second room. It is to be understood, however, that theapparatus 10 may be designed to be larger or smaller depending, at leastin part, on the intended end use of the apparatus 10. For example, theapparatus 10 may be designed for small-scale environments, where smallquantities (e.g., between one and ten) instruments 12 are used such asin small medical offices or for home use. Typically, for small-scaleenvironments, the apparatus 10 may be compact and usably typically in aone room.

As shown, the apparatus 10 comprises a housing 14. The housing definesan interior 18. As shown, the housing 14 may include a plurality ofwalls 16 such as a first side wall 16 _(A), a second side wall 16 _(B),a front wall 16 _(C), and a rear wall 16T_(D) While the housing 14 shownin the figures has four walls 16 _(A), 16 _(B), 16 _(C), 16 _(D), it isto be appreciated that the housing 12 may have fewer than or more thanfour walls 16 and may have shapes other than rectangular or cylindricalshapes. For example, the housing 14 may have one wall 16, two walls 16,three walls 16, five walls 16, etc.

In an embodiment, and as shown, the housing 14 may further include aframe 20 that supports the various walls 16. One or more of the sidewalls 16 _(A) and 16 _(B) may contain at least one door 22 to allow auser to access to the interior 18 of the housing 12, e.g., for purposesof maintenance and/or cleaning. The door 22 may be hinged or may slidein a conventional manner. In another embodiment, one or more of the sidewalls 16 _(A) and 16 _(B) are panels that are at least partiallyremovable from the frame 20 to allow the user to access the interior 18of the housing 12. In this embodiment, the respective top and bottomportions of the side walls 16 _(A), 16 _(B) are positioned into top andbottom tracks defined by the frame 20. The side walls 16 _(A), 16 _(B)can be removed, for example, by moving (such as sliding) the side walls16 _(A), 16 _(B) along or in the tracks. In yet another embodiment, theside walls 16 _(A), 16 _(B) are integrally formed to frame 20 and arenot removable from the frame 20.

The housing 14 may further include front 24 and rear 26 ends. As shown,the front wall 16 _(C) is coupled to the frame 20, and is positioned atthe front end 24 of the housing 14. The front wall 16 _(C) includes anopening 28 defined in the front wall 16 _(C) that provides access to theinterior 18 of the housing 14. As will be described in further detailbelow, the opening 28 may be used as a loading venue for a rotatabledevice 76.

The housing 14 may further include a front door 30 which is coupled(such as mechanically coupled with fasteners or hinged) to the frontwall 16 _(C). The front door 30 may be described as a hatch or portalwhich may be opened to allow access to the interior 18 of the housing14. For example, the front door 30 moves between open and closedpositions relative to the opening 28. When in the open position, thefront door 30 provides access to the opening 28 and to the interior 18of the housing 14. It is to be understood that the front door 30 isconsidered to be in the opened position when the front door 30 exposesat least a portion of the opening 28 defined in the front wall 16 _(C).When in the closed position, the front door 30 completely closes off theopening 28 and access to the interior 18 of the housing 14 cannot beobtained through the opening 28.

In an example, the housing 14 further includes a hinge 32 for couplingthe front door 30 to the front wall 16 _(C) and for enabling the frontdoor 30 to move between the open and closed positions. The hinge 32 istypically mechanically coupled to the front wall 16 _(C), such as withone or more fasteners. The hinge 32 is also typically mechanicallycoupled to the front door 30, such as with one or more fasteners.

As shown, the front door 30 includes a handle 34 which may be held,gripped, and/or grasped by, for example, a user of the apparatus 10 foropening and closing the front door 30. The handle 34 may be a bar, arod, a plate, a knob, and/or the like. In an example, the handle 34 is abar or a rod that extends at least partially across a width W_(FD) ofthe front door 30. As shown, the handle 34 extends across and beyond thewidth W_(FD) of the front door 30. Further, the handle 34 may be coupledto the front door 30. Alternatively, and as shown, the handle may becoupled to the hinge 32. In this example, the handle 34 has two ends 36,38, and the handle 34 is coupled to the hinge 32 at one of the ends 36,38. As shown, the handle 34 is coupled to the hinge 32 at the end 36.

The housing 14 may further include a locking mechanism 40 for lockingthe front door 30 when in the closed position. In an example, thelocking mechanism 40 includes a first locking member 42 coupled to thefront door 30 and a second locking member 44 coupled to the front wall16 _(C). The second locking member 44 is complementary to and configuredto mate with the first locking member 42. In another example, the firstlocking member 42 may be coupled to the handle 34 and the second lockingmember 44 may be coupled to the front wall 16 _(C). The first lockingmember 42 may be coupled to one of the ends 36, 38 of the handle 34. Asshown, the first locking member 42 is coupled to the end 38 while thehinge 32 is coupled to the other end 36. In an example, the lockingmechanism 40 may include one or more pneumatic rotating lockingcylinders (not shown) coupled to the housing 14 for latching the frontdoor 30 to the housing 14 when the front door 30 is in the closedposition.

In an example, and as shown, e.g., in FIG. 4, the hinge 32 is coupled tothe housing 14 and has a hinge axis A_(H). The apparatus 10 may furtherinclude a motor 46 (such as a rotating or electric motor) that isoperatively coupled to the front door 30. In an example, the motor 46operates to move the front door 30 between the open and closedpositions. In an example, the motor 46 may operate the front door 30directly. In another example, the motor 46 may operate the front door 30utilizing a timing belt system (not shown). For instance, the front door30 may have an axle (not shown), and the timing belt system causes theaxle of the front door 30 to rotate or spin about the hinge axis A_(H).Where the motor 46 is present, a handle 34 is not required for the frontdoor 30.

As shown, e.g., in FIGS. 1-3, the rear wall 16 _(D) is coupled to theframe 20, and is positioned at the rear end 26 of the housing 14. Therear wall 16 _(D) includes another opening (not shown) defined in therear wall 16 _(D) that also provides access to the interior 18 of thehousing 14. As will be described in further detail below, the otheropening may be used as an unloading venue for the rotatable device 76.

The housing 14 further includes a rear door 50 which is coupled (such asmechanically coupled) to the rear wall 16 _(D). The rear door 50 may bedescribed as a hatch or portal which may be opened for access to theinterior 18 of the housing 14. For example, the rear door moves betweenopen and closed positions relative to the other opening. When in theopen position, the rear door 50 provides access to the other opening andto the interior 18 of the housing 14. It is to be understood that therear door 50 is considered to be in the opened position when the reardoor 50 exposes at least a portion of the opening other opening definedin the rear wall 16 _(D). When in the closed position, the rear door 50may completely close off the other opening and access to the interior 18of the housing 14 cannot be obtained through the other opening.

The rear door 50 may have a similar or different design as the frontdoor 30. In one example, the rear door 50 is a mirror image or a 180°rotated copy of the front door 30, and operates in the same manner asthe front door 30. However, the timing of the opening and closing therear door 50 may be independent of the timing of opening and closing thefront door 30. For instance, the front door 30 may be in the openposition and the rear door 50 may be in the closed position when loadingthe rotatable device 76. Further, the front door 30 is in the closedposition and the rear door 50 is in the open position when unloading therotatable device 76.

As shown in FIGS. 3, 5, and 6, the apparatus 10 further comprises avessel 52 within the interior 18 of the housing 14. The vessel 52includes at least one wall 54 and defines a chamber 56. In an example,the vessel 52 has a single, continuous wall 54 and is generallycylindrical. Alternatively, the vessel 52 may otherwise have a pluralityof walls 54 defining a polygonal-shaped vessel, such as aquadrilateral-shaped vessel, a pentagonal-shaped vessel, ahexagonal-shaped vessel, a heptagonal-shaped vessel, an octagonal-shapedvessel, etc. Additionally, the vessel 52 defines a longitudinal axisA_(V) extending between the first 58 and second 60 ends of the vessel52. The vessel 52 may comprise various materials, such as steel,plastic, and other materials that will be resistant to the cleaningfluids and mechanical strain generated during the cleaning processes.

The chamber 56, which is defined by the vessel 52, typically reflectsthe internal shape of the vessel 52. In the illustrated embodiment, thechamber 56 is cylindrically-shaped. The chamber 56 also extends alongthe longitudinal axis A_(V) of the vessel 52. In an example, and asshown, the vessel 52 defines a single (i.e., one) chamber 56. In anotherexample, the vessel 52 defines two or more independent chambers.

The vessel 52 also defines a port 62. Alternatively, the vessel 52 mayinclude a plurality of ports 62. As shown, the port 62 is one of aplurality of ports 62 extending along the vessel 52. In an example, theplurality of ports 62 is positioned in an orientation that issubstantially parallel to the longitudinal axis A_(V) of the vessel 52.However, it should be understood that the ports 62 may be located atvarious other positions of the vessel 52, and may be arranged in otherorientations. For example, several strips of ports 62 may be locatedaround the vessel 52 such that the ports 62 are equidistant from oneanother in the radial and/or longitudinal dimensions. Some of the ports62 may be used for at least partially filling the chamber 56 with thecleaning fluid. Other 62 ports may be used for injecting air or water.The ports 62 may be shaped and sized according to the type of fluidbeing transmitted therethrough.

The apparatus 10 further includes an injector 64 operatively coupled(e.g., mechanically attached) to the vessel 52 and in fluidcommunication with one or more of the ports 62. As shown, the injector64 is one of a plurality of injectors 64 with each injector 64operatively coupled to the vessel 52 and in fluid communication with arespective one of the ports 62. The injector(s) 64 may be coupled to awater source (not shown) by a connector 67 for injecting water retrievedfrom the water source into the chamber 56 through the port 62 andtowards the instrument 12. The water is typically injected into thechamber 56 during a rinsing phase of the cleaning method. Details of thecleaning method are set forth below. Further, the injector(s) 64typically injects water by spraying the water into the chamber 56. In anexample, the injector(s) 64 injects the water into the chamber 56 at aflow rate of, for example, from 0.1 to 20 gallons per minute (gpm). Inan example, the water sprayed into the chamber 56 by the injector(s) 64may be pressurized. The pressurized water may effectively remove thecleaning fluid from the exterior and/or interior the instrument duringthe rinsing step of the cleaning method. Additionally, the water whichis sprayed during the rinsing phase may be solely water, and typicallydoes not include any chemical-based cleaning fluids, soaps, detergents,or antimicrobial compounds.

In an example, one or more of the injector(s) 64 may be coupled (such asmechanically attached) to an air source (not shown) a connector 67 forinjecting air retrieved from the air source into the chamber 56. The airmay be injected through one or more of the ports 62 and towards theinstrument 12. It is to be understood that the ports 62 for injectingair into the chamber 56 may different from the ports 62 for filling thechamber 56 with the cleaning fluid. The air that is injected into thechamber 56 may be at room temperature (such as from 20 to 25° C.) or maybe heated. The heated air may have a temperature of from 35 to 45° C.The air may be injected into the chamber 56 during a cleaning phase toheat the cleaning fluid at least partially filling the chamber 56. Theair may also or otherwise be injected into the chamber 56 during adrying phase of the cleaning method to partially or completely dry theinstrument 12 after the instrument 12 has gone through a cleaning phaseof the cleaning method. In an example, the air may be heated utilizingan inline electrical resistance heater (not shown) with a spiral woundopen coil heating element. The heater is typically located upstream ofthe port 62 defined in the vessel 52 which is in fluid communicationwith the injector 64.

In an example, the apparatus 10 further comprises a valve 66 operativelycoupled (such as mechanically attached) to the vessel 52 for controllingflow of the cleaning fluid into the chamber 56 through the one or moreports 62. As shown, the valve 66 is one of a plurality of valves 66operatively coupled to the vessel 52. The valve 66 may be positionedsuch that the valves are parallel to the longitudinal axis A_(V) of thevessel 56. It should be understood that the one or more valves 66 mayalso be positioned in various orientations relative to the vessel 52.The valve(s) 66 is operatively coupled to a cleaning fluid, and controlsthe passage of the cleaning fluid from the cleaning fluid source througha pipe, a tube, a conduit, a duct, a channel, and/or the like (notshown), and into the chamber 56. Typically, the valve(s) 66 is coupledto the pipe, tube, conduit, duct, channel, and/or the like utilizing aconnector 67. In an example, when the valve(s) 66 is opened, thecleaning fluid flows into the chamber 56 and at least partially fillsthe chamber 56 with the cleaning fluid. It is to be understood that thevalve(s) 66 may allow flow of the cleaning fluid in one direction, suchas from the cleaning fluid source to the chamber 56. In an example, theapparatus 10 may further include a drain valve 68 to drain the cleaningfluid from the chamber 56 of the vessel 52.

The valve(s) 66 may include multi-turn valve configurations orquarter-turn valve configurations. Multi-turn valves typically have aclosure member that is displaced linearly by turning a stem multipletimes. Some non-limiting embodiments of multi-turn valves include gatevalves, needle valves, and pinch valves. Quarter-turn valves typicallyhave a closure member that turns 0° to 90° between a fully open positionand a fully closed position. Some non-limiting embodiments ofquarter-turn valves include ball valves, butterfly valves, plug valves,and spherical valves.

As previously mentioned, the valve(s) 66 may be opened to introduce thecleaning fluid into the chamber 56. This typically occurs during thecleaning phase of the cleaning method. Additionally, the valve(s) 66 maybe used to control the flow rate of the cleaning fluid as the cleaningfluid is introduced into the chamber 56. In an example, the valve(s) 66introduce the cleaning fluid into the chamber 56 at any desirable flowrate. Further, the flow rate of the cleaning fluid can vary or remainconstant as the chamber 56 is being at least partially filled.

In an example, the apparatus 10 further comprises an ultrasonictransducer 70 operatively coupled (such as mechanically attached) to thevessel 52 for delivering ultrasonic energy to the cleaning fluid in thechamber 56. As shown, the ultrasonic transducer 70 is one of a pluralityof ultrasonic transducers 70 operatively coupled to the vessel 52. Theplurality of ultrasonic transducers 70 may be aligned parallel to thelongitudinal axis A_(V) of the vessel 52. Alternatively, the ultrasonictransducers 70 may be positioned in alternative arrangements relative tothe vessel 52. For example, the ultrasonic transducers may be positionedin an equidistant manner along the circumference around the vessel 52and/or parallel to the longitudinal axis A_(V) of the vessel 52.

The ultrasonic transducer(s) 70 are used for delivering ultrasonicenergy to the cleaning fluid inside the chamber 56 of the vessel 52. Theultrasonic transducers 70 can also be described as sonication devicesfor applying sound energy to the cleaning fluid that is disposed withinthe chamber 56 to sonicate (e.g. induce fluid cavitation by deliveringultrasonic energy to) the cleaning fluid inside the chamber 56. Incertain embodiments, to work properly, the ultrasonic transducers 70directly contact the cleaning fluid inside the chamber 56. As such, theultrasonic transducers 70 may be arranged in a manner so that theycontact cleaning fluid when the chamber is at least 50, 60, 70, 80, or90% filled with the cleaning fluid.

Each ultrasonic transducer 70 may operate at a power output of from 0.5to 1.5 kilowatts (kW). In another example, each ultrasonic transducer 70may operate at a power output of from 0.75 kW to 1.25 kW. In oneparticular example, each ultrasonic transducer 70 may operate at a poweroutput of about 1 kW. Additionally, when a plurality of ultrasonictransducers 70 are present, the ultrasonic transducers 70 collectivelyhave, for example, a power output of from 0.1 to 10 kW. In anotherexample, the ultrasonic transducers 70 collectively operate at a poweroutput of from 1 kW to 9 kW. Furthermore, the ultrasonic transducer(s)70 apply ultrasonic energy to the cleaning fluid inside the chamber 56at an ultrasonic frequency of from 40 to 140 kilohertz (kHz). In anotherexample, the ultrasonic transducer(s) 70 apply ultrasonic energy to thecleaning fluid inside the chamber 56 at an ultrasonic frequency of from120 to 140 kHz. In still another embodiment, the ultrasonic transducers70 apply ultrasonic energy to the cleaning fluid inside the chamber 56at an ultrasonic frequency of about 132 kHz.

The inventors surprisingly discovered that sonication of the cleaningfluid inside the chamber 56 at the aforementioned ultrasonic frequencyranges effectively removes or breaks up particles of debris, dirt,biological fluids, contaminants, and/or the like from both the interiorand exterior surfaces of the instrument 12.

In an example, the apparatus 10 may include a controller 72 in selectivecommunication with each of the ultrasonic transducers 70. The controller72 is configured to control the power output and frequency of each ofthe ultrasonic transducers 70. For example, the controller 72 mayindependently control the frequency and power of each ultrasonictransducer 70, or the controller 72 may control the frequency and powerof multiple ultrasonic transducers 70 at once. The controller 72 is orincludes a processing unit having a non-transitory, computer-readablestorage medium with one or more executable programs stored thereon. Oneof the executable programs includes computer-readable instructions forautomatically setting each ultrasonic transducer 70 to a particularpower and/or frequency output. In an example, the program includescomputer-readable instructions for setting all of the ultrasonictransducers 70 to one particular power output. In another example, theprogram includes computer-readable instructions for setting each of theultrasonic transducers 70 to a different power output. The controller 72may also be used for monitoring the ultrasonic energy delivered by eachof the ultrasonic transducers 70. For example, the controller 72includes another executable program including computer-readableinstructions for measuring the amount of ultrasonic energy (i.e., thepower output) by determining a percentage of the ultrasonic energy beingdelivered by each of the ultrasonic transducers 70. The amount ofultrasonic energy may be used by the controller 72, for example, formaking adjustments to the power output of one or more of the ultrasonictransducers 70.

In an example, the apparatus 10 further includes a vacuum pump 74operatively coupled (such as mechanically attached, such as throughpipes, conduits, etc. or fastened directly to and in fluid communicationdirectly with the vessel 52) to the vessel 52 for depressurizing thechamber 56 of the vessel 52. Said differently, the vacuum pump 74 isused for creating at least a partial vacuum in the chamber 56.Depressurization of the chamber 56 involves removing air from within thechamber 56. Depressurization of the chamber 56 also involves removingair bubbles from the cleaning fluid inside the chamber 56 of the vessel52. The removal of air/air bubbles from the cleaning fluid ensures thatmolecules of the cleaning fluid, rather than molecules of air, directlycontact and/or clean the debris, dirt, biological fluid, etc. on thesurface(s) of the instrument 12. In other words, the depressurization ofthe chamber 56 ensures that air does not interfere with the action ofthe vibrating cleaning fluid. In an example, the vacuum pump 74depressurizes the chamber 56 to achieve a maximum vacuum level insidethe chamber 56 of about 25 inches of Hg. In an example, the pressure ofthe chamber 56 when depressurized ranges from atmospheric pressure(which is about 29.9 inches of Hg) to 25 inches of Hg.

Referring to FIGS. 1 and 7-11, the apparatus 10 further includes therotatable device 76, which is removably disposable in the chamber 56 ofthe vessel 52. The rotatable device 76 is used for supporting, holding,and/or retaining the instrument(s) 12 during a cleaning process ormethod. The rotatable device 76 defines a longitudinal axis A_(R), andthe rotatable device 76 is rotatable about the longitudinal axis A_(R).As shown, the rotatable device 76 has a base 78 having at least onesupport member 80 with first 82 and second 84 end members coupled (suchas mechanically, metallurgically, and/or chemically attached) to thesupport member 80. In an example, the support member 80 includes aplurality of hollow beams 81 that form a grid. However, it should beappreciated that the rotatable device 76 may have different structuresso long as the rotatable device 76 can rotate within the chamber 56 ofthe vessel 52.

The rotatable device 76 may include a fluid delivery member 86. Thefluid delivery member 86 may be oriented transverse to the longitudinalaxis A_(R) of the rotatable device 76. In other words, the fluiddelivery member 86 may be oriented such that the fluid delivery member86 extends away from the rotational axis of the rotatable device 76. Asshown, the fluid delivery member 86 is one of a plurality of fluiddelivery members 86. The fluid delivery member 86 may be a pin, a stem,a projection, or any suitable structure capable of delivering fluid. Asshown in FIG. 11, for example, the fluid delivery member 86 has an inlet88 and an outlet 90 and defines a fluid channel 92 extending between theinlet 88 and the outlet 90. In an example, the outlet 90 is defined atthe tip of the fluid delivery member 86. In another example, the outlet90 is defined at the side of the fluid delivery member 86. In stillanother example, the outlet 90 is defined at a distal end of the fluiddelivery member 86. In still another example, the fluid delivery member86 may have a plurality of outlets 90 with one outlet 90 defined at thetip of the fluid delivery member 86 and one or more outlets 90 definedat the side of the fluid delivery member 86. The inlet 88 may be definedat the bottom of the fluid delivery member 86 as shown. The fluiddelivery member(s) 86 may be dimensioned in various manners such thatthey are capable of delivering cleaning fluid to the interior of theinstruments being cleaned.

As will be described in further detail below, the cleaning fluid iscirculated utilizing a fluid transmission system 106 from the chamber 56and through the fluid channel 92 of the fluid delivery members 86 duringthe cleaning phase of the cleaning method.

In an example, the rotatable device 76 further includes a wheel 94coupled (such as mechanically, metallurgically, and/or chemicallyattached) to the base 78. More specifically, the wheel 94 is coupled toone of the first 82 or second 84 end members of the base 78. As shown,the wheel 94 is coupled to the end member 82 of the base 78. In anexample, the wheel 94 includes a plurality of teeth 96 that interlockswith teeth of a gear (not shown) disposed on the vessel 52. Typically,the gear rotates in response to a rotational force applied to the gearfrom, e.g., a motor or some other power source (not shown), to rotatethe wheel 94 which causes the rotatable device 76 (which includes thewheel 94) to rotate as well. While the rotatable device 76 is shownincluding a single (i.e., one) wheel 94, it is to be understood that therotatable device 76 may include a wheel 94 coupled to both end members82, 84 of the rotatable device 76. In this case, the two gears would becoupled to the vessel 52 for interlocking with the teeth 96 of thewheels 94 and rotate the rotatable device 76.

The rotatable device 76 further includes a rack 98 defining a cavity 100for supporting the instrument 12. The rack 98 is attachable to therotatable device 76, such as to the support member 80. The rack 98 mayalso extend parallel to the longitudinal axis A_(R) of the rotatabledevice 76. In an example, the rotatable device 76 includes a single(i.e., one) rack 98, which extends along the length of the rotatabledevice 76 and parallel to the longitudinal axis A_(R). In anotherexample, and as shown, the rotatable device 76 includes a plurality ofracks 98 which are aligned and/or are adjacent to one another and eachextends along a portion of the length of the rotatable device 76.

In an example, and as shown in FIG. 8, the rack(s) 98 has a top 102 andbottom 104 portions with each portion 102, 104 having a plurality ofrods defining a grid-like structure. In an example, each rack 98 definesa plurality of cavities 100 between the top 102 and bottom 104 portionswith a fluid delivery member 86 extending towards each of the cavities100. However, it should be appreciated that the rack 98 may have otherconfigurations so long as the rack 98 is capable of securing theinstrument(s) 12 during the cleaning method or process. An example ofanother configuration of the rack 98 is shown in FIG. 9. In thisexample, the top and bottom portions 102, 104 have slots rather than agrid-like structure. Additionally, the bottom portion 104 is at leastpartially removable from the top portion 102 for loading of theinstrument(s) 12 in the rack 98, and the bottom portion 104 isattachable to the top portion 102 (e.g., after the instrument(s) 12 hasbeen loaded) utilizing fasteners, buckles, clasps, etc.

Typically, each fluid delivery member 86 aligns with a respectiveinstrument 12 to be cleaned. In certain embodiments, the fluid deliverymember 86 may be placed within (or at least partially within) theinterior and/or the lumen of the instrument 12 as the instrument 12 isloaded into the rack 98. In one example, the fluid delivery member 86may also hold, support, and/or retain the instrument 12. In anotherexample, the instrument 12 may be held, supported, and/or retained bythe top and bottom portions 102, 104 of the rack 98. In an example, thetop portion 102 of the rack 98 may be vertically adjusted to accommodatefor any type, shape, and/or design of the instrument 12. Further, whencleaning a plurality of instruments 12, the top portion 102 may haveapertures each defining a portion of a cavity 100 at each instrumentlocation, where the narrowest portion of the instrument 12 is allowed topass through the top portion 100 while the widest portion of theinstrument 12 remains inside the cavity 100 and acts as a shoulder. Thisconfiguration typically prevents undesirable movement and/or passage ofthe instrument 12 through the rack 98 during the cleaning method.

It is to be understood that the instrument 12 is loosely (i.e., notrigidly) held, supported, and/or retained by the fluid delivery member86 and/or the rack 98 so that the instrument 12 does not get damaged(e.g. broken, cracked, scraped, etc.) during the cleaning method.Further, by virtue of being loosely held, supported, and/or retained bythe fluid delivery member 86 and/or the rack 98, the instrument 12 canoscillate slightly while the rotatable device 76 rotates and/or whilethe ultrasonic transducers 70 sonicate the cleaning fluid. For example,oscillation of the instrument 12 occurs due, at least in part, to therotational motion of the rotatable device 76 while submerged in thecleaning fluid inside the chamber 56 during the cleaning method.Additionally, the fluid delivery member 86 and the cavity 100 of therack 98 are designed so there is/are dimensional clearance(s) betweenthe fluid delivery member 86 and the instrument 12.

In instances where the instrument 12 does not call for internalcleaning, the rotatable device 76 may not include a fluid deliverymember 86. In this instance, the top portion 102 of the rack 98 may besufficient to prevent undesirable movement of the instrument 12 withinthe rack 98.

As previously mentioned, the apparatus 10 may further include a fluidtransmission system 106. The fluid transmission system 106 may be influid communication with the chamber 56 and the fluid channel 92 of thefluid delivery member 86 for circulating the cleaning fluid from thechamber 56 through the fluid channel 92 of the fluid delivery member 86.In the example shown in FIG. 11, the fluid transmission system 106 has aconduit 108 in fluid communication with the chamber 56 and a pump 110operatively coupled (such as mechanically attached) to the conduit 108for circulating the cleaning fluid from the chamber 56 through the fluidchannel 92 of the fluid delivery member 86. For example, the instrument12 is submerged in the cleaning fluid which at least partially fills thechamber 56. When submerged, the cleaning fluid contacts the exterior ofthe instrument 12 as well as the interior of the instrument 12. Thecleaning fluid is retrieved from the chamber 56, and is transportedthrough the conduit 108 and into the fluid channel 92 of the fluiddelivery member 86. The fluid flows through the fluid channel 92 andthrough the outlet(s) 90 defined in the fluid delivery member 86. Based,at least in part, on the flow rate of the cleaning fluid flowing throughthe conduit 106 and the fluid channel 92, the cleaning fluid jets out ofthe outlet(s) 90 of the fluid delivery member 86 and contacts theinterior surface(s) and/or lumen of the instrument 12. Additionally,since the instrument 12 is submerged in the cleaning fluid in thechamber 56, the interior of the instrument 12 is already filled withcleaning fluid. Accordingly, the cleaning fluid that is jetted from thefluid delivery member 86 contacts the cleaning fluid already presentinside the instrument 12. Said differently, the jetting of the cleaningfluid from the fluid delivery member 86 occurs at or through aliquid-to-liquid interface. Accordingly, when jetted, the cleaning fluiddoes not contact air. It is to be understood that the design of thefluid delivery member 86 is specific for achieving the desirable jettingof the cleaning fluid into the interior of the instrument 12 that occursat or through a liquid-to-liquid interface. It is further to beunderstood that the jetting of the cleaning fluid into the interior ofthe instrument 12 cannot be accomplished by a nozzle (i.e., a devicethat utilizes a spray or atomization of a liquid through air (e.g. viaan air interface) under pressure.

In the example depicted in FIG. 11, the conduit 108 extends through thehollow beams 81 of the support member 80. Alternatively, the supportmember 80 may be solid and bottom portion of the rack 98 may be hollow.In this case, the conduit 108 may extend through the bottom portion 104of the rack 98 and is in fluid communication with the inlet 88 of thefluid delivery member 86. Also in this case, the bottom portion 104 ofthe rack 98 may be attached to the support 80 and the top portion 102may be removable for loading the instrument(s) 12.

In an example, the apparatus 10 further includes a receptacle 112 forholding the cleaning fluid. A conduit 114 is in fluid communication withthe receptacle 112 and with the port 62 of the vessel 52 for at leastpartially filling the chamber 56 with the cleaning fluid. The conduit114 further has a valve (such as the valve 66) for controlling flow ofthe cleaning fluid from the receptacle to the chamber 56. In an example,the apparatus 10 has a plurality of receptacles 112 each for holding adifferent cleaning fluid, and a has a plurality of conduits 114 and anassociated pump 116 with each conduit 114 in fluid communication with arespective one of the receptacles 112.

In an example, the pump 116 is a positive displacement pump. Somenon-limiting embodiments of positive displacement pumps include rotarypumps, diaphragm pumps, piston displacement pumps, gear pumps, and thelike. Typically, the pump 116 pulls the cleaning fluid from thereceptacle 112 and the valve 116 controls the flow rate of the cleaningfluid into the chamber 56. In an example, the cleaning fluid enters thechamber 56 at a flow rate of up to about 44 gallons per minute (gpm).However, other flow rates are also contemplated depending on the scaleof the apparatus.

In an example, and as shown in FIGS. 2 and 3, the pump(s) 116 may besituated adjacent to or inside the housing 14. In another example, thepump(s) 116 may be situated on a tray 118 that is moveable between openand closed positions. An example of the open position of the tray 118 isshown in FIG. 3, while an example of the closed position of the tray 118is shown in FIG. 2. The tray 118 may be received inside the housing 14through, e.g., an aperture 120 formed in the front wall 16 _(C) of thehousing 14. As shown, the tray 118 includes a base 122 that supports thepump(s) 116 and a side panel 124. Opposing sides of the base 122 may bereceived in tracks (not shown) formed in the frame 20 of the housing 14,allowing the base 122 to be moveable relative to the housing 14 alongthe tracks. When the tray 118 is in the closed position, the base 122 ofthe tray 118 may be completely received in the housing 14, and the sidepanel 124 covers the aperture 120 and forms part of the front wall 16_(C).

In an example, the cleaning apparatus 10 further includes a processor126 for operating the apparatus 10 according to a predetermined cleaningprotocol. The processor 126 may be a general purpose central processingunit (CPU), a graphics processing unit (GPU), a microcontroller, areduced instruction set computer (RISC) processor, an applicationspecific integrated circuit (ASIC), a programmable logic circuit (PLC),and/or any other circuit or processor capable of executing functionsassociated with the apparatus 10. The processor 126 has anon-transitory, computer-readable storage medium with a plurality ofexecutable programs stored thereon. Each of the executable programscontains computer-readable instructions for a respective, predeterminedcleaning protocol. The cleaning protocol typically includes one or moresteps for cleaning the instrument 12. The steps may include, but are notlimited to, a high power rinse step, a chamber filling step, a washingstep, a draining step, and a drying step. The cleaning protocol alsoincludes various parameters that are used during the cleaning, such asflow rates of the cleaning fluid, rinse water, and/or air, pressureinside the chamber 56, power output of the ultrasonic transducers 70,duration (in terms of seconds, minutes, hours, etc.) for each step,fluid and/or air temperature, etc.

The cleaning protocols may be created by a user of the apparatus 10,such as an operator and/or an engineer of the apparatus 10. The cleaningprotocol can be saved or stored as one of a plurality of cleaningprotocols, and all of the cleaning protocols remain resident on theprocessor 126 of the apparatus 10. Alternatively, the cleaningprotocol(s) may be customized ad hoc such that users of the instrumentscan create new protocols. Further, the apparatus 10 includes a userinterface 128 (such as a display screen with a keyboard and mouse, atouch screen, and/or the like), which is operatively associated with theprocessor 124, for selecting a particular cleaning protocol from theplurality of cleaning protocols resident on the processor 124.

Additionally, and in an example, the processor 124 may be used tocontrol and/or activate various incidental components/aspects of theapparatus 10. For instance, the processor 124 may be used for activatingthe motor 46 coupled to the front door 30 for opening and closing thefront door 30. For instance, the processor 124 may also be used foractivating a motor coupled to a gear on the vessel 52 for initiatingrotation of the rotatable device 76.

Also disclosed herein is a method for cleaning the instrument 12utilizing the apparatus 10. The method includes loading the instrument12 in the rotatable device 76; specifically, in the cavity 100 of therack 98. For example, the top portion 102 of the rack 98 is removed fromthe bottom portion 104, or visa versa depending on the design orconfiguration of the rack 98. The instrument 12 may be aligned with thefluid delivery member 86, and the fluid delivery member 86 is placedwithin, or at least partially within, the interior and/or lumen of theinstrument 12. The instrument is placed in the cavity 100 and the topportion 102 of the rack 98 is placed back on the bottom portion 104 withat least a portion of the instrument 12 being supported between the top102 and bottom 104 portions of the rack 98.

After the instrument 12 is loaded, the method involves placing therotatable device 76 inside the chamber 56 of the vessel 52. In anexample, and as shown in FIGS. 1 and 12A-12D, the rotatable device 76may be loaded with the assistance of a cart 130. The cart 130, forexample, may be any type of a holder for the rotatable device 76 whenthe rotatable device 76 is outside of the chamber 56 of the vessel 52.In an example, the cart 130 may be supported by wheels so that the cart130 can be easily moved from one place to another (e.g. for loading therotatable device 76 at the front end 24 of the housing 14).

As shown in FIGS. 12A-12D, the loading of the rotatable device 76includes opening the front door 30, for example, by unlatching thelocking mechanism 40 and moving the front door 30 from the closedposition to the open position. As shown in FIG. 12A, the loading stepfurther includes moving (e.g. sliding) the rotatable device 76 fromoutside of the chamber 56, through the front door 30, and into thechamber 56. In some examples, the loading step further includespositioning the cart 130 (with the rotatable device 76 disposed on thecart 130) adjacent the first door 30 and then pushing the rotatabledevice 76 off of the cart 130, through the front door 30, and into thechamber 56 of the vessel 52. Once the rotatable device 76 has beenplaced inside the chamber 56 of the vessel 52, the method furthercomprises closing the front door 30 and locking the front door 30 withthe locking mechanism 40. It is to be understood that when the frontdoor 30 and the rear door 50 are closed (and locked), an air-tight andliquid-tight seal is formed within the chamber 56.

Before or after the rotatable device 76 has been loaded into the chamber56 of the vessel 52, the user of the apparatus 10 selects one of thepredetermined cleaning protocols stored in the processor 126 utilizingthe user interface 128. While the cleaning protocols differ in terms ofnumber and/or sequence of operational steps and various operationalparameters, each protocol typically defines a cleaning method having acleaning phase, a rinsing phase, and a drying phase. The cleaning phasemay include a pre-rinsing stage and a cleaning stage. The pre-rinsingstage involves rinsing the instrument 12 prior to applying the cleaningfluid to the instrument 12, and the cleaning stage involves applying thecleaning fluid to the instrument 12. The rinsing step includes rinsingthe instrument 12. While the rinsing phase typically occurs after thecleaning step, in some instances, the rinsing step may also occur priorto the cleaning step. The rinsing step may include a first rinsing stagewhere the exterior of the instrument 12 is rinsed and a second rinsingstage where the interior of the instrument 12 is rinsed. The dryingphase includes drying the instrument 12.

During the cleaning phase, the method comprises at least partiallyfilling the chamber 56 with the cleaning fluid to submerge theinstrument 12 in the cleaning fluid. The step of at least partiallyfilling the chamber 56 may be accomplished by retrieving the cleaningfluid from the receptacle 112 and controlling flow of the cleaning fluidfrom the receptacle to the chamber 56 with the valve 66. As previouslymentioned, the valve 66 may be opened to introduce the cleaning fluidinto the chamber 56 at any desirable flow rate. Typically, the chamber56 (with the rotatable device 76 inside the chamber 56) is completelyfilled with the cleaning. However, completely filling the chamber 56with the cleaning solution is not required so long as the instrument 12is completely submerged in the cleaning fluid inside the chamber 56. Inan example, the cleaning fluid fills at least 75% of the chamber 56volume. In still another embodiment, the cleaning fluid fills at least85% of the chamber 56 volume.

The method further includes rotating the rotatable device 76 within thechamber 56. In an example, the rotatable device 76 rotates within thechamber 56 at a rate of from 0.5 to 1.5 rpm. In another example, therotatable device 76 rotates within the chamber 56 at a rate of from 0.8to 1.2 rpm. Alternatively still, the rotatable device 76 may rotatewithin the chamber at a rate of 0.1 to 10 rpm. The rotation of therotatable device 76 may be initiated by the processor 126 according tothe selected cleaning protocol by powering the motor operatively coupledto the vessel 52 which causes the gear coupled to the vessel 52 torotate.

It is to be understood that while the rotatable device 76 rotates withinthe chamber 56, at least one of the fluid delivery member 86 and theinstrument 12 oscillate within the rack 98. As previously described, byvirtue of being loosely held, supported, and/or retained by the fluiddelivery member 86 and/or the rack 98, the instrument 12 can oscillateslightly while the rotatable device 76 rotates while the instrument 12is submerged in the cleaning fluid. Additionally, the fluid deliverymember 86 may also oscillate based, at least in part, on how the fluiddelivery member 86 is coupled to the rotatable device 76. Oscillatorymovement of the instrument 12 and/or the fluid delivery member 86 causesthe cleaning fluid to flow against the interior and exterior surfaces ofthe instrument 12 for removing at least part of the dirt, debris,biological fluids, etc. from the surfaces of the instrument 12.

It is to be understood that the cleaning phase is accomplished, at leastin part, when the instrument 12 is submerged in the cleaning fluid thatat least partially fills the chamber 56 of the vessel 52. Accordingly,in certain embodiments, the cleaning fluid is not sprayed over theinstrument 12 through air during the cleaning phase.

The method further comprises sonicating the cleaning fluid in thechamber with the ultrasonic transducer 70. In an example, the apparatus10 includes a plurality of ultrasonic transducers 70 and the sonicatingstep involves sonicating the cleaning fluid with the ultrasonictransducers 70 with a collective power output of, for example, from 0.1to 10 kW. Additionally, the sonicating step further involves sonicatingthe cleaning fluid with the ultrasonic transducers 70 at a frequency of,for example, from 40 to 140 kHz. In an example, sonication utilizing aplurality of ultrasonic transducers 70 each having a power output offrom 0.1 to 10 kW and delivering ultrasonic energy at a frequency offrom 40 to 140 kHz effectively breaks up particles of the biologicalfluid or other contaminant(s) for easy removal of the biological fluidor other contaminant(s) from the surface(s) of the instrument 12.

In an example, the method further includes depressurizing the chamber 56during the cleaning phase. Depressurization of the chamber 56 may beaccomplished by creating at least a partial vacuum inside the chamber 56by evacuating the atmosphere in the chamber 56 to a pressure of from 15to 25 inches of Hg with the vacuum pump 74.

The sonicating and depressurizing steps may occur separately during thecleaning phase. Alternatively, the sonicating and depressurizing stepsoccur at the same time. For instance, during the cleaning phase, theinstrument 12 is cleaned utilizing sonication while depressurizing thechamber 56. In an example, the chamber 56 is depressurized and thesonication occurs in while the chamber 56 is being depressurized. Inanother example, depressurization of the chamber 56 occurs aftersonication has commenced. In both examples, sonication occurs in thepresence of the at least partial vacuum. Sonication while pulling the atleast partial vacuum may effectively remove biological fluid or othercontaminant(s) from both the interior and exterior surfaces of theinstrument 12. When the at least partial vacuum is appliedsimultaneously with sonication, air is removed from the chamber 56 andthe interior and/or lumen of the instrument 12 so that molecules of thecleaning fluid can directly contact the interior of the instrument 12.Also, when the at least partial vacuum is applied simultaneously withsonication, air is removed from the chamber 56 and from the cleaningsolution so that molecules of the cleaning solution can directly contactthe exterior of the instrument 12.

In an example, the heat may also be applied to the chamber 56 during thesonicating and depressurizing. In an example, heat may be applied byinjecting heated air into the chamber 56 utilizing the injector(s) 64.In another example, heat may be applied by pre-heating the cleaningfluid prior to introducing the cleaning fluid into the chamber 56. Theair and/or cleaning fluid may be heated using a suitable heating device.

In an example, the rotatable device 76 is rotated continuously, at theprescribed rate in rpm, during the sonicating and depressurizing steps.In another example, the rotatable device 76 is intermittently rotatedduring the sonicating and depressurizing steps. In the later example,the rotatable device 76 may be rotated periodically (such as every 10seconds, every 30 seconds, etc.). In still another example, therotatable device 76 is not rotated at all during the sonicating anddepressurizing steps.

During the cleaning phase, the method further comprises circulating thecleaning fluid through the fluid channel 92 of the fluid delivery member86 such that the cleaning fluid exits the fluid delivery member 86 tocontact the interior of the instrument 12. In an example, the fluidtransmission system 106 retrieves the cleaning fluid from inside thechamber 56 and circulates the cleaning fluid through the fluid channel92 of the fluid delivery member 86. For example, the cleaning fluidenters the inlet 88 of the fluid delivery member 86, flows through thefluid channel 92, and exits the fluid delivery member 86 through theoutlet 90. It is to be understood that when the cleaning fluid exits thefluid channel 92 through the outlet 90, the cleaning fluid contactscleaning fluid already inside the interior of the instrument 12.Accordingly, the cleaning fluid exiting the fluid delivery member 86enters liquid inside the instrument 12; and not air. In an example, thecirculating step occurs separately from, or simultaneously with thesonicating and/or depressurizing steps.

After the cleaning phase is complete, in an example, the cleaning methodenters the rinsing phase which includes injecting a rinse water into thechamber 56 through the at least one port 62 towards the instrument 12.In an example, the rinse water is injected (e.g. via spraying), underpressure, inside the chamber 56 utilizing the injector 64. Typically,the rinse water is injected while the rotatable device 76 is rotatinginside the chamber 56. The rinse water contacts the rotatable device 76,and contacts the instrument 12 retained by the rotatable device 76, toremove any debris from the instrument 12. The rinse water along with thedebris may be drained from the chamber 56 via, e.g., the drain valve 68which may be located at the lowest point of the vessel 52. Water may bedrained using the drain valve 68 that can be manually operated orautomatically operated by the processor 126.

As previously mentioned, the rinsing phase of the cleaning method mayinclude first and second rinsing stages. During the first rinsing stage,the method comprises rinsing the exterior surface(s) of the instrument12 with a rinse water to remove additional debris and cleaning fluidfrom the exterior surface(s) of the instrument 12. In an example, themethod comprises rotating the rotatable device 76 further (e.g. at arate of from 0.5 to 1.5 rpm) while simultaneously introducing (e.g.spraying) a rinse water, under pressure, into the chamber 56 via theinjector 64. The rinse water is typically used to rinse off the exteriorsurface(s) of the instrument 12 that was just in contact with thecleaning fluid during the previous cleaning phase.

It is to be understood that the cleaning phase and first rinsing stagedescribed above may be applied once to the instrument 12, or may beapplied several (e.g. two or more) times. The number of cleaning phasesand first rinsing stages that are applied may be controlled by theprocessor 124 according to the selected cleaning protocol.

In an embodiment, the method further includes the second rinsing stage.During the second rinsing stage, the method comprises rinsing theinterior surface(s) of the instrument 12 with a rinse water to removeadditional debris and cleaning fluid from the interior of the instrument12. In an example, the method comprises retrieving the rinse water froma rinse water supply, passing the rinse water through the fluidtransmission system 106 and into the fluid channel 92 of the fluiddelivery member 86. The rinse water exits the fluid delivery member 86through the outlet 90 and into the interior of the instrument 12. Themethod further comprises draining the rinse water from the chamber 56,such as with the drain valve 68. The second rinsing stage may beaccomplished separately from the first rinsing stage, or simultaneouslywith the first rinsing stage.

After rinsing the exterior and interior surfaces of the instrument 12,the method further comprises rotating the rotatable device 76 (again ata rate of from 0.5 to 1.5 rpm) while evacuating the atmosphere in thechamber 56. This may be accomplished utilizing the vacuum pump 74.Additionally, and during a drying phase of the cleaning method, themethod involves introducing heated air into the chamber 56 to dry theinstrument 12. In an example, the heated air used for drying has atemperature of from 40 to 50° C., and drying utilizing the heated airmay be accomplished using, e.g. a 10 minute drying cycle time.

When the drying phase is complete, the method further comprisesunlocking the rear door 50 and moving the rear door 50 to an openposition. The method comprises moving the rotatable device 76 (e.g. viasliding) out of the chamber 56 through the rear door 50. The methodfurther comprises removing the instrument 12 from the rotatable device76.

A specific embodiment of a cleaning protocol is set forth below:

-   -   1. Sliding the rotatable device 76 from an interior of the        chamber 56 to an exterior of the chamber 56 for loading;    -   2. Loading the one or more instruments 12 (such as trocars) into        respective cavities 100 of the rack 98, where the instruments 12        are lined up with a respective one of the fluid delivery members        86;    -   3. Sliding the loaded rotatable device 76 from the exterior of        the chamber 56 to the interior of the chamber 56 for cleaning;    -   4. Locking the front 30 and rear 50 doors;    -   5. Rotating the rotatable device 76 at approximately 1 rpm while        simultaneously spraying a rinse water, under pressure, through        the injectors 64 to contact the instruments 12 and remove large        debris from the instruments 12;    -   6. Draining the chamber 56 of the rinse water and the large        debris;    -   7. Filling the chamber 56 with a cleaning fluid such that the        chamber 56 fills from the bottom to the top of the chamber 56;    -   8. Sonicating the cleaning fluid in the chamber 56 at a        frequency of about 132 kHz utilizing the ultrasonic transducers        70;    -   9. Evacuating an atmosphere in the chamber 56 to approximately        20 inches of Hg utilizing the vacuum pump 74;    -   10. Transmitting the cleaning solution through the fluid        transmission system 106 into the interior of the instruments 12        simultaneously with, or independently from, steps 7, 8, and/or        9;    -   11. Optionally rotating the rotatable device 76 simultaneously        with steps 7, 8, 9, and/or 10;    -   12. Draining the chamber 56 of the cleaning fluid;    -   13. Rotating the rotatable device 76 at approximately 1 rpm        while simultaneously spraying a rinse water, under pressure, to        contact the instruments 12;    -   14. Repeating steps 7, 8, 9, 10, 11, and 12;    -   15. Filling the chamber 56 with rinse water utilizing the        injectors 64;    -   16. Repeating steps 8, 9, and 10;    -   17. Transmitting the rinse water through the fluid transmission        system 106 into the interior of the instruments 12        simultaneously with, or independently from, any one or more        parts of step 16;    -   18. Draining the chamber 56 of the rinse water;    -   19. Repeating step 13;    -   20. Rotating the rotatable device 76 at approximately 1 rpm        while simultaneously evacuating the atmosphere in the chamber 56        utilizing the vacuum pump 74 and injecting heated air through        the injectors 64 to dry the instruments 12;    -   21. Unlocking and opening the rear door 50; and    -   22. Removing the rotatable device 76 from the chamber 56 and        removing the instruments 12 from the rotatable device 76.

The apparatus 10 and method described above may be used to efficientlyand effectively clean both the interior and the exterior of instruments,such as medical instruments. The apparatus 10 utilizes cleaningprotocols to perform the cleaning method with process controls so thatthe instruments 12 may be cleaned within acceptable cleaning standards.Yet further, the apparatus requires less handling of the instruments 12during cleaning, which reduces breakages or damage to the instruments 12as well as the individual components of the apparatus 10.

While the invention has been described with reference to the examplesabove, it will be understood by those skilled in the art that variouschanges may be made and equivalents may be substituted for elementsthereof without departing from the scope of the invention. In addition,many modifications may be made to adapt a particular situation ormaterial to the teachings of the invention without departing from theessential scope thereof. Therefore, it is intended that the inventionnot be limited to the particular embodiment disclosed as the best modecontemplated for carrying out this invention, but that the inventionwill include all examples falling within the scope of the appendedclaims.

What is claimed is:
 1. An apparatus for cleaning an instrument with acleaning fluid, wherein the instrument has a lumen, and said apparatuscomprising: a vessel defining a chamber and a port for at leastpartially filling said chamber with the cleaning fluid; an ultrasonictransducer operatively coupled to said vessel for delivering ultrasonicenergy to the cleaning fluid in said chamber; a vacuum pump operativelycoupled to said vessel for depressurizing said chamber; a rotatabledevice removably disposable in said chamber and defining a longitudinalaxis with said rotatable device being rotatable about said longitudinalaxis and having a rack defining a cavity for supporting the instrument,said rotatable device further having a projection extending towards saidcavity of said rack for jetting the cleaning fluid into the lumen of theinstrument with said projection having a length for at least partiallyextending into the lumen of the instrument and said projection definingan inlet for receiving the cleaning fluid, an outlet for jetting thecleaning fluid into the lumen of the instrument, and a fluid channelextending along said length between said inlet and said outlet; and afluid transmission system in fluid communication with said chamber andsaid fluid channel of said projection for circulating the cleaning fluidfrom said chamber through said fluid channel of said fluid deliverymember.
 2. The apparatus as set forth in claim 1 wherein said fluidtransmission system has a conduit in fluid communication with saidchamber and a pump operatively coupled to said conduit for circulatingthe cleaning fluid from said chamber through said fluid channel of saidprojection.
 3. The apparatus as set forth in claim 1 wherein saidrotatable device further has a base and a wheel coupled to said basewith said projection coupled to and extending from said base.
 4. Theapparatus as set forth in claim 1 further comprising: a receptacle forholding the cleaning fluid; a conduit in fluid communication with saidreceptacle and said port of said vessel for at least partially fillingsaid chamber with the cleaning fluid with said conduit having a valvefor controlling flow of the cleaning fluid from said receptacle to saidchamber.
 5. The apparatus as set forth in claim 1 further comprising aninjector operatively coupled to said vessel and in fluid communicationwith said chamber with said injector operable for injecting water intosaid chamber or for injecting air into said chamber.
 6. The apparatus asset forth in claim 5 wherein said vessel defines a longitudinal axis andsaid port is one of a plurality of ports defined parallel to saidlongitudinal axis of said vessel and said injector is one of a pluralityof injectors with each of said injectors operatively coupled to saidvessel and in fluid communication with a respective one of said ports.7. The apparatus as set forth in claim 1 further comprising a processorhaving a non-transitory, computer-readable storage medium with aplurality of executable programs stored thereon with each of saidexecutable programs containing computer-readable instructions for arespective, predetermined cleaning protocol.
 8. The apparatus as setforth in claim 1 wherein said ultrasonic transducer is one of aplurality of ultrasonic transducers and said apparatus further comprisesa controller in selective communication with each of said plurality ofultrasonic transducers for controlling a power output of each of saidplurality of ultrasonic transducers.